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  1. Book ; Online ; E-Book: Methodologies in biosimilar product development

    Lee, Sang Joon / Chow, Shein-Chung

    (Chapman & Hall/CRC Biostatistics Series)

    2022  

    Abstract: Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but ...

    Author's details edited by Sang Joon Lee, Shein-Chung Chow
    Series title Chapman & Hall/CRC Biostatistics Series
    Abstract "Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval"--
    Keywords Drug development ; Biologicals
    Subject code 615.19
    Language English
    Size 1 online resource (393 pages)
    Publisher CRC Press
    Publishing place Boca Raton, FL
    Document type Book ; Online ; E-Book
    Remark Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
    ISBN 1-00-320580-1 ; 1-003-20580-1 ; 1-000-45191-7 ; 0-367-89634-6 ; 978-1-00-320580-7 ; 978-1-003-20580-7 ; 978-1-000-45191-7 ; 978-0-367-89634-8
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  2. Book ; Online ; E-Book: Advanced statistics in regulatory critical clinical initiatives

    Zhang, Wei / Yan, Fangrong / Chen, Feng / Chow, Shein-Chung

    (Chapman and Hall/CRC biostatistics series)

    2022  

    Author's details edited by Wei Zhang, Fangrong Yan, Feng Chen, and Shein-Chung Chow
    Series title Chapman and Hall/CRC biostatistics series
    Keywords Electronic books
    Language English
    Size 1 Online-Ressource (x, 307 Seiten), Illustrationen
    Edition First edition
    Publisher CRC Press, Taylor & Francis Group
    Publishing place Boca Raton
    Publishing country United States
    Document type Book ; Online ; E-Book
    Remark Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
    HBZ-ID HT021344411
    ISBN 978-1-000-56799-1 ; 978-1-003-10732-3 ; 9780367561789 ; 9780367609955 ; 1-000-56799-0 ; 1-003-10732-X ; 0367561786 ; 0367609959
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

    Full text online

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  3. Article ; Online: Empower clinical development by harnessing data from diverse sources: methodology, applications and regulatory perspectives.

    Deng, Shibing / Chow, Shein-Chung

    Journal of biopharmaceutical statistics

    2024  , Page(s) 1–2

    Language English
    Publishing date 2024-04-01
    Publishing country England
    Document type Editorial
    ZDB-ID 1131763-2
    ISSN 1520-5711 ; 1054-3406
    ISSN (online) 1520-5711
    ISSN 1054-3406
    DOI 10.1080/10543406.2024.2333529
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 3511: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  4. Article ; Online: On the use of RWD in support of regulatory submission in drug development.

    Chow, Shein-Chung / Wang, Peijin

    Journal of biopharmaceutical statistics

    2024  , Page(s) 1–28

    Abstract: For the approval of a drug product, the United States Food and Drug Administration requires substantial evidence (SE) regarding effectiveness and safety of the test drug to be provided. In recent years, the use of real-world data in support of regulatory ...

    Abstract For the approval of a drug product, the United States Food and Drug Administration requires substantial evidence (SE) regarding effectiveness and safety of the test drug to be provided. In recent years, the use of real-world data in support of regulatory submission of pharmaceutical development has received much attention, and real-world evidence (RWE) is treated as complementary to SE by evaluating the real-world performance of the test treatment. In this article, we start by summarizing current regulatory perspectives on drug evaluation and some potential challenges in using RWE. To test for superiority in co-primary endpoints, a two-stage hybrid RCT/RWS adaptive design that combines randomized control trial for providing SE and real-world study for generating RWE is proposed. We use superiority in effectiveness and non-inferiority in safety as an example to illustrate how to implement this design. Numerical studies have shown that the proposed design has merits in reducing the required sample size compared with traditional co-primary endpoint tests while maintaining statistical power and controlling type I error inflation. The proposed design can be implemented in drug development considering co-primary endpoints, especially for oncology and rare disease drug development.
    Language English
    Publishing date 2024-03-19
    Publishing country England
    Document type Journal Article
    ZDB-ID 1131763-2
    ISSN 1520-5711 ; 1054-3406
    ISSN (online) 1520-5711
    ISSN 1054-3406
    DOI 10.1080/10543406.2024.2330213
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 3511: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  5. Article ; Online: Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift.

    Mai, Weijia / Chow, Shein-Chung

    Journal of biopharmaceutical statistics

    2024  , Page(s) 1–14

    Abstract: ... objectives, and study endpoints are the same at different stages, Chow (2020) classified two-stage seamless ... In this article, following similar ideas proposed by Chow and Lin (2015) and Chow (2020), a statistical method ...

    Abstract In recent years, clinical trials utilizing a two-stage seamless adaptive trial design have become very popular in drug development. A typical example is a phase 2/3 adaptive trial design, which consists of two stages. As an example, stage 1 is for a phase 2 dose-finding study and stage 2 is for a phase 3 efficacy confirmation study. Depending upon whether or not the target patient population, study objectives, and study endpoints are the same at different stages, Chow (2020) classified two-stage seamless adaptive design into eight categories. In practice, standard statistical methods for group sequential design with one planned interim analysis are often wrongly directly applied for data analysis. In this article, following similar ideas proposed by Chow and Lin (2015) and Chow (2020), a statistical method for the analysis of a two-stage seamless adaptive trial design with different study endpoints and shifted target patient population is discussed under the fundamental assumption that study endpoints have a known relationship. The proposed analysis method should be useful in both clinical trials with protocol amendments and clinical trials with the existence of disease progression utilizing a two-stage seamless adaptive trial design.
    Language English
    Publishing date 2024-03-21
    Publishing country England
    Document type Journal Article
    ZDB-ID 1131763-2
    ISSN 1520-5711 ; 1054-3406
    ISSN (online) 1520-5711
    ISSN 1054-3406
    DOI 10.1080/10543406.2024.2330204
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 3511: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    ab Jg. 2022: Lesesaal (EG)

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  6. Article ; Online: The use of real-world data for clinical investigation of effectiveness in drug development.

    Wang, Peijin / Chow, Shein-Chung

    Journal of biopharmaceutical statistics

    2024  , Page(s) 1–24

    Abstract: With the growing interest in leveraging real-world data (RWD) to support effectiveness evaluations for new indications, new target populations, and post-market performance, the United States Food and Drug Administration has published several guidance ... ...

    Abstract With the growing interest in leveraging real-world data (RWD) to support effectiveness evaluations for new indications, new target populations, and post-market performance, the United States Food and Drug Administration has published several guidance documents on RWD sources and real-world studies (RWS) to assist sponsors in generating credible real-world evidence (RWE). Meanwhile, the randomized controlled trial (RCT) remains the gold standard in drug evaluation. Along this line, we propose a hybrid two-stage adaptive design to evaluate effectiveness based on evidence from both RCT and RWS. At the first stage, a typical non-inferiority test is conducted using RCT data to test for not-ineffectiveness. Once not-ineffectiveness is established, the study proceeds to the second stage to conduct an RWS and test for effectiveness using integrated information from RCT and RWD. The composite likelihood approach is implemented as a down-weighing strategy to account for the impact of high variability in RWS population. An optimal sample size determination procedure for RCT and RWS is introduced, aiming to achieve the minimal expected sample size. Through extensive numerical study, the proposed design demonstrates the ability to control type I error inflation in most cases and consistently maintain statistical power above the desired level. In general, this RCT/RWS hybrid two-stage adaptive design is beneficial for effectiveness evaluations in drug development, especially for oncology and rare diseases.
    Language English
    Publishing date 2024-03-22
    Publishing country England
    Document type Journal Article
    ZDB-ID 1131763-2
    ISSN 1520-5711 ; 1054-3406
    ISSN (online) 1520-5711
    ISSN 1054-3406
    DOI 10.1080/10543406.2024.2330215
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 3511: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  7. Book: Controversial statistical issues in clinical trials

    Chow, Shein-Chung

    (Chapman & Hall/CRC biostatistics series)

    2011  

    Author's details Shein-Chung Chow
    Series title Chapman & Hall/CRC biostatistics series
    Keywords Drug Evaluation, Preclinical ; Clinical Trials as Topic ; Data Interpretation, Statistical
    Language English
    Size XIX, 591 S. : graph. Darst.
    Publisher CRC Press
    Publishing place Boca Raton, Fla
    Publishing country United States
    Document type Book
    HBZ-ID HT016350656
    ISBN 978-1-4398-4961-3 ; 1-4398-4961-7
    Database Catalogue ZB MED Medicine, Health

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    In stock of ZB MED Cologne/Königswinter

    Shelf markLoan statusLocation
    2011 A 3198 order for loan Magazin

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  8. Article ; Online: Innovative thinking of clinical investigation for rare disease drug development.

    Wang, Peijin / Chow, Shein-Chung

    Orphanet journal of rare diseases

    2023  Volume 18, Issue 1, Page(s) 299

    Abstract: For the development of a test treatment or drug product, it is necessary to conduct composite hypothesis testing to test for effectiveness and safety simultaneously, since some approved drug products have been recalled due to safety concerns. One of the ... ...

    Abstract For the development of a test treatment or drug product, it is necessary to conduct composite hypothesis testing to test for effectiveness and safety simultaneously, since some approved drug products have been recalled due to safety concerns. One of the major issues in conducting a composite hypothesis testing for effectiveness and safety is the requirement of a huge sample size to achieve the desired power for detecting clinically meaningful differences in both safety and effectiveness. Situation can be much difficult in orphan drug development. In this article, a generalized two-stage innovative approach to test for effectiveness and safety simultaneously is proposed. Additionally, to alleviate the requirement of a large randomized clinical trial (RCT) and revealing effectiveness, real-world data is suggested to use in conjunction with RCT data for orphan drug development. The proposed approach can help investigators test for effectiveness and safety at the same time without worrying about the sample size. It also helps reduce the probability of approving a drug product with safety concerns.
    MeSH term(s) Humans ; Rare Diseases/drug therapy ; Drug Development ; Research Design ; Sample Size ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2023-09-22
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2225857-7
    ISSN 1750-1172 ; 1750-1172
    ISSN (online) 1750-1172
    ISSN 1750-1172
    DOI 10.1186/s13023-023-02909-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Book: Design and analysis of bridging studies

    Liu, Jen-Pei / Chow, Shein-Chung / Hsiao, Chin-Fu

    (Chapman & Hall/CRC biostatistics series)

    2013  

    Author's details ed. by Jen-pei Liu ; Shein-Chung Chow ; Chin-Fu Hsiao
    Series title Chapman & Hall/CRC biostatistics series
    Keywords Clinical Trials as Topic / standards ; Drug Evaluation, Preclinical / standards ; Internationality ; Biostatistics / methods ; Guidelines as Topic ; Research Design
    Language English
    Size XVIII, 269 S. : graph. Darst.
    Publisher CRC Press
    Publishing place Boca Raton u.a.
    Publishing country United States
    Document type Book
    HBZ-ID HT017052900
    ISBN 978-1-4398-4634-6 ; 9781439846353 ; 1-4398-4634-0 ; 1439846359
    Database Catalogue ZB MED Medicine, Health

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    In stock of ZB MED Cologne/Königswinter

    Shelf markLoan statusLocation
    2012 A 3841 order for loan Magazin

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  10. Book: Encyclopedia of biopharmaceutical statistics

    Chow, Shein-Chung

    2003  

    Author's details ed. by Shein-Chung Chow
    Keywords Biopharmaceutics / methods ; Drug Design ; Data Interpretation, Statistical ; Statistics / methods ; Research Design
    Language English
    Size VIII, 1055 S. : graph. Darst.
    Edition 2. ed., rev. and expanded
    Publisher Dekker
    Publishing place New York u.a.
    Publishing country United States
    Document type Book
    HBZ-ID HT013548410
    ISBN 0-8247-4261-3 ; 978-0-8247-4261-4
    Database Catalogue ZB MED Medicine, Health

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    In stock of ZB MED Cologne/Königswinter

    Shelf markLoan statusLocation
    2008 A 7343 order for loan Magazin

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